Methadone Maintenance Treatment Outcome Study in Taiwan (M0508)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by National Health Research Institutes, Taiwan.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT01093248
First received: March 24, 2010
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

Opioid abuse is a complex problem, which not only impacts on the affected individuals' physical and psychological health, but also threatens public security and the productivity of the society. Further, through needle sharing and sexual contacts, injecting drug users (IDUs) have become laden with HIV and HIV related health problems, representing a serious public health threat all over the world. In Taiwan, since the identification of the first HIV-infected IDU in 1987, the incident cases have continued to increase, reaching a height of 2,461 in 2005. In order to contain the epidemics of HIV among IDUs, and to prevent its spread to the population in general, the Center for Disease Control (CDC) collaborated with the Department of Justice to initiate and implement a number of harm reduction programs in 2005. The fact that opioid addiction is officially treated as a health rather than a legal issue itself represents a remarkable milestone in Taiwan. Among these harm reduction programs, including needle and syringe exchange for IDUs as well as substitution treatment approaches for opioid dependence, methadone maintenance treatment (MMT) perhaps represents the most most important and most crucial component. Remarkably, in a relatively short time span, more than 60 MMT programs were established, which enrolled more than 15,000 heroin addicts. This notwithstanding, the overall and differential effectiveness of these MMT service delivery systems, as well as the characteristics of these programs and the patients that might contribute toward treatment response or failure remain largely unknown. Such knowledge base is crucial for establishing standardized and feasible outcome evaluation processes for opioid addicts receiving MMT programs, as well as for the further improvement of the efficacy and effectiveness of these programs, in Taiwan.

In order to address some of these issues, this study adopts a multi-site, prospective clinical follow-up design. It aims at establishing a research network for examining MMT outcome, developing standardized MMT outcome assessment instruments and procedures, and identifying predictors of MMT outcome. The findings may contribute to the better understanding of the characteristics of opioid addicts, the effectiveness of MMT and remaining service needs for opioid addicts in Taiwan.


Condition
Heroin Addiction

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Methadone Maintenance Treatment Outcome Study in Taiwan

Resource links provided by NLM:


Further study details as provided by National Health Research Institutes, Taiwan:

Estimated Enrollment: 300
Study Start Date: July 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Heroin-addicted Patients
Heroin-addicted outpatient department (OPD) patients who seek help for methadone maintenance treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

heroin-addicted patients who seek help for methadone maintenance treatment

Criteria

Inclusion Criteria:

  • Be 18 years or older.
  • Be fulfilling the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria of opiate dependence.
  • Be agree to and capable of signing informed consent form that has been approved by an Institution Review Board.

Exclusion Criteria:

  • Have ever participated in the study at one of the collaborative hospitals/clinics.
  • Be expecting to discontinue methadone treatment for any reason (leaving the methadone clinic's geographic area, pending legal action, etc.) in the following 3 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093248

Contacts
Contact: Chun-Yu Chen, MS 886-37-246166 ext 36747 cyc@nhri.org.tw

Locations
Taiwan
Departments of Psychiatry, Wei-Gong Memorial Hospital Recruiting
Miaoli, Taiwan
Contact: Ming-Lun Liu, MD         
Principal Investigator: Ming-Lun Liu, MD         
Departments of Psychiatry, China Medical University and Hospital Recruiting
Taichung, Taiwan
Contact: Chieh-Liang Huang, MD         
Principal Investigator: Chieh-Liang Huang, MD         
Departments of Psychiatry, Far-Eastern Memorial Hospital Recruiting
Taipei, Taiwan
Contact: Chi-Shin Wu, MD         
Principal Investigator: Chi-Shin Wu, MD         
Sub-Investigator: Kai-Chi Fang, MD         
Departments of Psychiatry, Taipei City Hospital Song-De Campus Recruiting
Taipei, Taiwan
Contact: Lien-Wen Su, MD         
Principal Investigator: Lien-Wen Su, MD         
Departments of Psychiatry, Taipei City Hospital Yang-Ming Campus Recruiting
Taipei, Taiwan
Contact: Yih-Hong Yang, MD         
Principal Investigator: Yih-Hong Yang, MD         
Sub-Investigator: Yung-Chun Fang, MD         
Departments of Psychiatry, En-Chu-Kong Hospital Recruiting
Taipei County, Taiwan
Contact: Li-Nen Lin, MD         
Principal Investigator: Li-Nen Lin, MD         
Sub-Investigator: Yen-Feng Lin, MD         
Departments of Psychiatry, Tao-yuan Psychiatric Center Recruiting
Tao-Yuan, Taiwan
Contact: Happy Kuy-Lok Tan, MD, MPH         
Principal Investigator: Happy Kuy-Lok Tan, MD, MPH         
Sub-Investigator: Sun-Yuan Chou, MD         
Sub-Investigator: Kuen-Hong Wu, MD         
Sponsors and Collaborators
National Health Research Institutes, Taiwan
Investigators
Principal Investigator: Sheng-Chang Wang, M.D.,M.Sc. National Health Research Institutes, Taiwan
  More Information

No publications provided

Responsible Party: National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier: NCT01093248     History of Changes
Other Study ID Numbers: 99A1-PHPP39, 99A1-PHPP39
Study First Received: March 24, 2010
Last Updated: August 14, 2012
Health Authority: Taiwan: National Health Research Institutes

Additional relevant MeSH terms:
Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on October 19, 2014